The Ethics of Implausible Medical Claims (IMC)

In Part 2 of this series* we learned from David Katz, MD, a key member of the Yale School of Medicine’s “integrative medicine” program, that he had been “pushed toward integrative medicine by the needs of [his] patients.” We also learned that Dr. Katz’s rationale for this decision justifies a wide range of quackery—both in principle and in fact. I had previously alluded to arguments like those of Dr. Katz in a comment on SBM several months ago:

…we must be true to medical ethics, no matter what else we do. If that means losing a few patients, so be it. Patients are free agents, and we can only do so much to influence them. To the extent that we don’t do that as well as we might (which is obviously true in some cases), we might do better. But our ethical obligation is to science and truth; it is not, as many modern physicians would have it and as much as we may lament sometimes losing patients to woo, to seducing patients to stick with us no matter what, if the “what” includes engaging in a charade about “integration” or “complementary therapies”…

Realizing that some might argue that physicians’ obligations to patients ought to trump their obligations to “science and truth,” I later revised that statement:

Several weeks ago I argued here that a physician’s primary ethical obligation is to science and truth. In retrospect I probably should have put it a slightly different way: a physician’s primary ethical obligation is the same as everyone else’s. It is to honesty and integrity. For physicians, however, that means being true to real medical knowledge, among other things, and real medical knowledge comes from science.

In spite of that revision, two readers whose opinions I respect challenged my assertion. Dr. Peter Moran’s worthy efforts to educate patients about the realities of “alternative” cancer treatments are considerable. Here on SBM he has repeatedly challenged us to explain how, when confronted with testimonials of “alternative” cures, we ought to respond without using “a high-handed, ‘we know best’ stance” and thus “appear to want to distance [ourselves] from the intimate concerns of [our] patients.” I was thinking mainly of him when I wrote the revision above, because on this key topic—how to respond ethically, but with compassion, to patients who want to believe in implausible treatments—I’ve come to think of Dr. Moran as the “conscience” of Science-Based Medicine. Those with cancer, he has reminded us, “are folk very like you and me who are simply grasping at any straw that might save or prolong their lives.” His take on why IMCs are appealing to those with less ominous problems is well-developed and agrees with my own, mostly. We part ways, however, when he concludes (also here and here) that ethical physicians might have good reasons—unlike Dr. Katz’s—to entertain benign, if implausible treatments:

I thought KA was similarly slightly off-target when defining the primary ethical obligations of the physician as being to science without even mentioning the patient. That would certainly apply in an ICU or in the operating theatre, and in most specialist neurological or oncological practices (hint!), but there may be quite sound reasons why many family doctors don’t yet want to completely abandon dubious but relatively safe methods in favour of the contents of their drug cabinet.

Co-blogger David Gorski also took issue with my assertion about honesty and integrity/science and reason:

…ethically as a physician, my first obligation is to the patient and seeing that the patient is treated as effectively as she can be (sorry, Kimball, my first obligation when treating a patient is not to science or reason). Telling a patient too stridently that her dubious therapy is, well, a dubious therapy risks doing one of two things: (1) driving her away from effective science-based therapy or (2) making her reluctant to tell me everything she is taking.

Dr. Gorski and I, however, don’t really disagree. The relevant terms in his passage and in my second passage quoted above are “primary,” “first,” and “too stridently.” I have no trouble with Dr. Gorski’s description of how he responds to patients who ask about or elect dubious treatments:

As long as they tell me about it and it doesn’t interfere with scientific-based treatment, patients can do whatever they like. If they ask my my opinion, I will tell them, as non-judgmentally as possible, but I’m not going to push too hard.

My original assertion about medical ethics, quoted above, did not argue that our obligation to science and reason trumps our obligation to our patients. It argued that our obligation to science and truth (reason is also fine) trumps “seducing patients to stick with us no matter what, if the ‘what’ includes engaging in a charade [see Dr. Katz] about ‘integration’ or ‘complementary therapies’…” Later I used the term “primary ethical obligation,” which was unfortunate because the word “primary” distracted from the real point: Honesty and integrity, which in medicine must not clash with science and reason, are necessary for fulfilling our ethical obligations to our patients.

It is beside the point to quibble over whether, on some numbered list, our obligation to our patients should precede or follow our obligation to honesty and integrity. We can’t fulfill our obligation to our patients if we don’t fulfill our obligation to honesty and integrity, and we can’t do that if we overlook science and reason.

Formal Treatises

Most modern statements of medical ethics include both an obligation to patients and an obligation to honesty and integrity, which in turn is either explicitly or implicitly linked to science. The recent “Medical Professionalism in the New Millennium: A Physician Charter,” a joint project of the American College of Physicians and the European Federation of Internal Medicine, has three Fundamental Principles, the first two of which are:

Principle of primacy of patient welfare. This principle isbased on a dedication to serving the interest of the patient.Altruism contributes to the trust that is central to the physician–patientrelationship. Market forces, societal pressures, and administrativeexigencies must not compromise this principle.

Principle of patient autonomy. Physicians must have respectfor patient autonomy. Physicians must be honest with their patientsand empower them to make informed decisions about their treatment.Patients’ decisions about their care must be paramount, as longas those decisions are in keeping with ethical practice anddo not lead to demands for inappropriate care.

There is also a Set of Professional Responsibilities, among which are:

Commitment to professional competence. Physicians must be committedto lifelong learning and be responsible for maintaining themedical knowledge and clinical and team skills necessary forthe provision of quality care. More broadly, the professionas a whole must strive to see that all of its members are competentand must ensure that appropriate mechanisms are available forphysicians to accomplish this goal.

Commitment to honesty with patients. Physicians must ensurethat patients are completely and honestly informed before thepatient has consented to treatment and after treatment has occurred.This expectation does not mean that patients should be involvedin every minute decision about medical care; rather, they mustbe empowered to decide on the course of therapy.

Commitment to scientific knowledge. Much of medicine’s contractwith society is based on the integrity and appropriate use ofscientific knowledge and technology. Physicians have a dutyto uphold scientific standards, to promote research, and tocreate new knowledge and ensure its appropriate use. The professionis responsible for the integrity of this knowledge, which isbased on scientific evidence and physician experience.

I. A physician shall be dedicated to providing competent medical care, with compassion and respect for human dignity and rights.

II. A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.

V. A physician shall continue to study, apply, and advance scientific knowledge, maintain a commitment to medical education, make relevant information available to patients, colleagues, and the public, obtain consultation, and use the talents of other health professionals when indicated.

VIII. A physician shall, while caring for a patient, regard responsibility to the patient as paramount.

It is unethical to engage in or to aid and abet in treatment which has no scientific basis and is dangerous, is calculated to deceive the patient by giving false hope, or which may cause the patient to delay in seeking proper care.

A physician may refer a patient for diagnostic or therapeutic services to another physician, limited practitioner, or any other provider of health care services permitted by law to furnish such services, whenever he or she believes that this may benefit the patient. As in the case of referrals to physician-specialists, referrals to limited practitioners should be based on their individual competence and ability to perform the services needed by the patient. A physician should not so refer a patient unless the physician is confident that the services provided on referral will be performed competently and in accordance with accepted scientific standards and legal requirements.

The following general guidelines are offered to serve physicians when they are called upon to decide among treatments: (1) Treatments which have no medical indication and offer no possible benefit to the patient should not be used (Opinion 2.035, “Futile Care”). (2) Treatments which have been determined scientifically to be invalid should not be used (Opinion 3.01, “Nonscientific Practitioners”).

The following guidelines encourage physicians to play a key role in identifying and preventing fraud: (1) Physicians must renew their commitment to Principle II of the American Medical Association’s Principles of Medical Ethics which states that “a physician shall deal honestly with patients and colleagues, and strive to expose those physicians deficient in character, competence, or who engage in fraud or deception.” (2) Physicians should make no intentional misrepresentations to increase the level of payment they receive or to secure non-covered health benefits for their patients.

The AMA: (1) does not recommend the sole use of unvalidated folk remedies to treat disease without scientific evidence regarding their safety or efficacy; (2) encourages research to determine the safety and efficacy of folk remedies; (3) physicians should be aware that the use of folk remedies may delay patients from seeking medical attention or receiving conventional therapies with proven benefit for disease treatment and prevention; (4) practicing physicians should routinely ask patients whether they are using folk medicine or family remedies for their symptoms. Physicians can educate patients about the level of scientific information available about the therapy they are using, as well as conventional therapies that are known to be safe and efficacious; and (5) physicians should be aware of folk remedies in use and the level of scientific information available about such remedies, and should include this information when discussing conventional treatments and therapies with their patients.

Policy of the AMA on alternative medicine is: (1) There is little evidence to confirm the safety or efficacy of most alternative therapies. Much of the information currently known about these therapies makes it clear that many have not been shown to be efficacious. Well-designed, stringently controlled research should be done to evaluate the efficacy of alternative therapies. (2) Physicians should routinely inquire about the use of alternative or unconventional therapy by their patients, and educate themselves and their patients about the state of scientific knowledge with regard to alternative therapy that may be used or contemplated. (3) Patients who choose alternative therapies should be educated as to the hazards that might result from postponing or stopping conventional medical treatment.

It is the policy of the AMA (1) to continue to monitor the published literature on clinical ecology and to report as appropriate; and (2) that those who support a new test, procedure, or treatment must prove by appropriately controlled peer reviewed trials that it is effective for the purposes for which it is used and that the burden should not be shifted to opponents to prove that a new test or therapy is invalid.

A placebo is a substance provided to a patient that the physician believes has no specific pharmacological effect upon the condition being treated. In the clinical setting, the use of a placebo without the patient’s knowledge may undermine trust, compromise the patient-physician relationship, and result in medical harm to the patient.

Physicians may use placebos for diagnosis or treatment only if the patient is informed of and agrees to its use. A placebo may still be effective if the patient knows it will be used but cannot identify it and does not know the precise timing of its use. A physician should enlist the patient’s cooperation by explaining that a better understanding of the medical condition could be achieved by evaluating the effects of different medications, including the placebo. The physician need neither identify the placebo nor seek specific consent before its administration. In this way, the physician respects the patient’s autonomy and fosters a trusting relationship, while the patient still may benefit from the placebo effect.

A placebo must not be given merely to mollify a difficult patient, because doing so serves the convenience of the physician more than it promotes the patient’s welfare. Physicians can avoid using a placebo, yet produce a placebo-like effect through the skillful use of reassurance and encouragement. In this way, the physician builds respect and trust, promotes the patient-physician relationship, and improves health outcomes (I, II, VIII).

Although the language could have been more definitive, it seems to me that the statements above deem it unethical for physicians to offer implausible treatments, to refer patients to others for implausible treatments, or, if asked, to fail to inform patients of the implausible nature of such treatments. They also deem it unethical to administer a placebo without the patient’s informed consent, or to mislead patients about the reasons that implausible treatments make some people feel better. Thus it is dishonest to recommend acupuncture or homeopathy in a disguised attempt to elicit a placebo effect.

I will not argue that physicians must, perforce, honor certain written edicts. On the contrary, if these treatises contained language condoning the cited practices, I would reject them. My reason for citing the statements above is not to pose as a petty, medical ethics traffic cop. It is to remind us that these ethical precepts have been considered at length by thoughtful, committed physician-ethicists, have been around long enough to have made their way into formal opinions, and have persisted in those opinions. Thus physicians practicing in disregard for them—especially those, such as Dr. Katz and other IMC enthusiasts, who have been flouting them for several years—should be aware that they have chosen to repudiate the considered opinions of wise men and women, regarding an issue that is fundamental to medical ethics: the relation of honesty and integrity to science and reason.

The medical profession as a whole ought to acknowledge that as well. The time has come for the profession to revisit those ethical precepts and decide whether they have become obsolete. If not, it’s time to clean house.